To hear about similar clinical trials, please enter your email below
Trial Title:
Prevention of Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients
NCT ID:
NCT06135493
Condition:
Peripheral Neuropathy Due to Chemotherapy
Conditions: Official terms:
Peripheral Nervous System Diseases
Losartan
Conditions: Keywords:
Paclitaxel
Breast Cancer
Peripheral Neuropathy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Losartan
Description:
Using losartan to prevent paclitaxel-induced peripheral neuropathy
Arm group label:
Intervention arm
Summary:
Paclitaxel-induced peripheral neuropathy (PIPN) is one of the most dose-limiting side
effects; it causes patients discomfort and pain and sometimes causes the termination of
the chemotherapy cycles, leading to treatment failure. A lot of interventions have been
tried to prevent PIPN, ensure complete administration of the chemotherapy cycles, and
increase the survival rate. One of the promising interventions in the prevention of PIPN
is Losartan. Losartan is an angiotensin receptor blocker (ARBs) and is used to treat
hypertensive patients. There is strong evidence from different preclinical studies and
retrospective cohort studies that Losartan has a neuroprotective effect.
The purpose of our study is to investigate the efficacy of Losartan in the prevention of
peripheral neuropathy associated with Paclitaxel treatment in Breast Cancer patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Females older than 18 years diagnosed with biopsy-confirmed breast cancer (Early
breast cancer eligible for adjuvant or neoadjuvant) who are scheduled to receive
paclitaxel 80 mg/m2.
Exclusion Criteria:
- Known hypersensitivity to Losartan.
- Not Known Hypertensive patients
- Not Known Diabetic patients
- Treatment with Losartan/ARBs/ACE-I prior to the study.
- Previous neuropathy
- Renal impairment (Serum creatinine > 2 mg/dl)
- Significant liver disease: liver enzymes 2 folds the upper normal limit
- Metastatic breast cancer
- Pregnancy or lactation
- Taking other medication for neuropathic pain
- Significant Hypotension
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Breast Cancer Comprehensive Center of the National Cancer Institute, Cairo University
Address:
City:
Cairo
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Farida Ali
Phone:
01228188969
Email:
faridaali.nci@gmail.com
Start date:
December 12, 2023
Completion date:
March 30, 2025
Lead sponsor:
Agency:
Future University in Egypt
Agency class:
Other
Source:
Future University in Egypt
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06135493
